The FDA, which has been on a campaign to get Indian drugmakers to conform with its regulations, slapped Unimark Remedies with another warning letter in which…

India’s Sun Pharma has had a host of problems at some of its own manufacturing facilities in India but it just narrowly escaped another warning letter for a…

The FDA recently issued another warning letter to Noven, a standalone operating subsidiary of Japan-based Hisamitsu Pharmaceuticals, for lapses at its Miami…

Sagent Pharmaceuticals ($SGNT) is widening its recall of antibiotics manufactured by one of its India-based contractors after a customer complained that small…

A new report shows international regulators were unimpressed with Pfizer’s operations at a Hospira plant in India during a recent inspection.  

Portola has gotten an FDA CRL largely focused on manufacturing issues for AndexXa, its breakthrough anticoagulant reversal agent. It joins a number of other…

Pfizer has decided that it does not need the legacy distribution sites that it got with the $15 billion buyout of Hospira last year and so will close four…

Life sciences company Agilent Technologies recently will invest $120 million on anew plant in Colorado to make nucleic acid APIs.